Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort

Recurrent Adult Soft Tissue Sarcoma Clinical Trial

Official title:

Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02701153
• Other study ID #: 15-001657
• Secondary ID: NCI-2016-0020215
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2016
• Est. completion date: February 3, 2026

Study information

• Verified date: February 2023
• Source: Jonsson Comprehensive Cancer Center
• Contact: Jackie Hernandez
• Phone: 310-206-8477
• Email: jhernandez[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase II trial studies the side effects of hypofractionated radiation therapy in treating patients with soft tissue sarcomas prior to surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Description:

PRIMARY OBJCETIVES:

I. Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema) at 2 years.

SECONDARY OBJECTIVES:

I. Evaluate local control, regional control, distant metastasis, progression free survival, and overall survival.

II. Evaluate the functional outcomes as assessed using the musculoskeletal tumor rating scale (MSTS) and the Toronto Extremity Salvage Score (TESS).

III. Collect germ-line deoxyribonucleic acid (DNA) and nucleic acids from cancer patients to further investigate the association and identify new germ-line mutations that impact cancer predisposition.

IV. Investigate the role of germ-line mutations in predicting cancer outcome and response to therapy.

OUTLINE:

Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.

After completion of study treatment, patients are followed up at 3 months and then every 6 months for 5 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: February 3, 2026
• Est. primary completion date: February 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed soft tissue sarcoma of the extremity/trunk

• Intermediate or high grade sarcoma

• Resectable primary lesion (patients with pre-existing metastasis will be included if their primary is still going to be resected)

• Recurrent, any grade, no previous radiation therapy

• Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG) 0 - 2

• If a woman is of childbearing potential, a negative serum pregnancy test must be documented

Exclusion Criteria:

• Active treatment of a separate malignancy

• History of prior irradiation to the area to be treated

• Pre-operative chemotherapy (post-op acceptable)

Related Conditions & MeSH terms

• Recurrent Adult Soft Tissue Sarcoma
• Sarcoma

Intervention

Procedure:
• Conventional Surgery
Undergo surgery

Radiation:
• Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (5)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	Radiological Society of North America, Sarcoma Alliance for Research through Collaboration, Sarcoma Foundation of America, Tower Cancer Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema)	Interim reports will be prepared every six months until the results of the study are published. In general, the interim reports will contain information about patient accrual rate with projected completion dates, status of question-answer (QA) review and compliance rate of treatment per protocol, and the frequencies and severity of toxicity.	Up to 2 years
Secondary	Distant metastasis	Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.	Up to 3 years
Secondary	Local failure	Cumulative incidence approach (Kaplan-Meier [K-M] plots and Cox proportional hazard modeling) will be used.	Up to 3 years
Secondary	Overall survival	Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.	Up to 3 years
Secondary	Progression free survival	Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.	Up to 3 years
Secondary	Regional failure	Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.	Up to 3 years